The first non-surgical repair for Pelvic Organ Prolapse

Informations projet

apyx

N° de convention de subvention: 190143220

DOI

10.3030/190143220

Projet clôturé

Date de signature de la CE 20 Novembre 2023

Date de début 1 Octobre 2023

Date de fin 30 Septembre 2025

Financé au titre de

• The European Innovation Council (EIC)

Coût total

€ 5 067 216,25

Contribution de l’UE

€ 2 500 000,00

Coordonné par

ESCALA MEDICAL LTD
Israel

Periodic Reporting for period 2 - apyx (The first non-surgical repair for Pelvic Organ Prolapse)

Période du rapport: 2024-10-01 au 2025-09-30

Résumé du contexte et des objectifs généraux du projet

Pelvic organ prolapse (POP) is a prevalent medical condition affecting women worldwide. POP occurs when pelvic organs (bladder, uterus, vagina or rectum) descend from their normal position, causing a range of symptoms including urinary incontinence, bowel dysfunction, and pelvic pain. This condition significantly impacts women's quality of life, affecting physical, psychological, and social well-being.
Escala's Mendit device represents a paradigm shift in POP treatment. It is an innovative, incision-free repair solution designed to address the unique challenges of treating POP.
Key features of the Mendit device:
o Incision-free repair method replacing the repair surgery offered to 10% of the patients at advanced stages of the condition
o Minimally invasive procedure that can be performed under local anesthesia in the doctor’s office
o Quick recovery time
o Cost-effective compared to traditional surgical options

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Mendit (formerly Apyx) is a FDA cleared device that allows women to restore pelvic floor function and regain their quality of life immediately. EIC project allowed the development, validation, and clinical testing of the design leading to a successful chance at commercial uptake in EU. Apart from this, the project allowed Escala Medical to:
1. Build strong visibility and engagement with stakeholders (via communication and dissemination activities).
2. Secure robust intellectual property protection, now including an allowed European patent that underpins regulatory and commercial expansion.
3. Deliver commercial traction and investor confidence, with rapid U.S. adoption and financial runway secured until 2027.
4. Advanced regulatory pathways with FDA clearances and CE marks on track for Q1 2026.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

Escala's Impact Strategy
1. Impact Objective

Escala aims to significantly improve the health and quality of life of women suffering from POP while generating competitive financial returns. The Mendit device is positioned to transform lives in developed as well as underserved communities where surgical options are limited or unavailable.
2. Key Impact Areas
o Increasing access to POP treatment
o Improving quality of life for women with POP
o Reducing social stigma associated with POP
o Empowering healthcare providers
3. Impact Targets for 2025-2030
o Treat thousands of women with POP using the Mendit device
o Establish partnerships with providers and distributors in target markets
o Train local healthcare providers on using the Mendit device
o Reduce average treatment costs for POP by over 50% compared to surgical options
o Substantially increase the availability of an incision-free prolapse repair option to populations in need
o Achieve a high patient satisfaction rate
4. Strategy to Achieve Impact
o Market Expansion: Leverage the established distribution agreement with the Singapore-based distributor to expand access in South East Asia. Establish distribution agreement with Europen distributors to commercialize the optimized Mendit device once CE mark is receievd. These strategic partnerships will help Escala navigate local regulatory and reimbursement environments and establish a presence in key markets.
o Pricing: Develop a tiered pricing strategy and model to ensure affordability in different markets. This approach recognizes the varying economic conditions and aims to make the Mendit device accessible to a broader range of patients.
o Awareness and Education: Partner with local NGOs and women's health organizations to raise awareness about POP and available treatments. This will help address the stigma associated with POP and encourage more women to seek treatment.
o Healthcare Provider Training: Implement training programs for local healthcare providers on using the Mendit device. This will build local capacity and ensure the sustainable delivery of POP treatment in target communities.
o Research: Conduct market research to quantify quality of life improvements and cost savings associated with the use of the Mendit device. This data will be crucial in demonstrating the device's value to healthcare systems and potential partners.
5. Measuring and Reporting Impact
Escala is committed to rigorous impact measurement and transparent reporting:
o Track the number of procedures performed, broken down by country and demographic data
o Conduct patient surveys to assess quality of life improvements and satisfaction
o Monitor training program participation and skills development of local providers and distribution partners
o Calculate cost savings compared to traditional surgical options
o Publish impact reports detailing progress towards targets and showcasing patient case studies

6. Balancing Impact and Financial Returns
Escala's strategy is designed to create both significant social impact and competitive financial returns. By addressing the large unmet need for POP treatment, Escala aims to:
o Expand its addressable market
o Build strong brand loyalty in target markets
o Create long-term value for all stakeholders
The company believes that by improving women's health outcomes, it can create a large and sustainable market that delivers both social impact and financial success

Apyx Device